RhinoconjunctivitisNCT01949428
House Dust Mite Observational Study
An observational study of Rhinoconjunctivitis, run by Circassia Limited at 1 site in Canada.
Trial summary
A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinoconjunctivitis
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis
Who may be able to join
- Male or female, aged 18-65 years
- A history of moderate to severe rhinoconjunctivitis (sneezing, rhinorrhoea, itchy nose, nasal blockage, and/or itchy/watery/red/sore eyes) consistent with allergy to HDM for at least 1 year.
- Non-asthmatic, or asthma controlled by Step 1 or 2 treatment as defined by GINA for at least one month.
- Subjects must have a 7-day reflective TRSS (i.e., reflective over the previous 7 days) of ≥12 and must have a score of ≥2 in at least two of the individual symptom components.
- Subjects must have Der p or Der f specific IgE ≥0.35 kU/L as measured by ImmunoCAP®. A blood draw for HDM-specific IgE must be performed during the Screening period.
- Subjects must have Der p or Der f specific IgE ≥0.35 kU/L as measured by ImmunoCAP®. A blood draw for HDM-specific IgE must be performed during the Screening period.
Who cannot join
- Clinically significant confounding symptoms of allergy to relevant local seasonal allergens (e.g., ragweed, mugwort, tree, grass, mountain cedar, mould) and cannot complete the Screening and Observation period outside the respective allergy seasons.
- Previous immunotherapy treatment with any HDMA for more than 1 month within 5 years prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects With a History of House Dust Mite-Induced Rhinoconjunctivitis
A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis
Read the detailed description
House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.
The proposed observational study is designed to gather information on subjects with HDM-related rhinoconjunctivitis.
- Conditions
- Rhinoconjunctivitis
- Keywords
- HDM Allergy, Rhinoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HDM-Induced Rhinoconjunctivitis Subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Document the combined Total Rhinocnjunctivitis Systom Scores (TRSS) and Total allergy medication score
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharm-Olam International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949428
- Sponsor's protocol ID
- TH003
- Status last verified
- May 2014
- First submitted
- 20 Sep 2013
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects With a History of House Dust Mite-Induced Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT01949428
- Acronym / sponsor ID
- TH003
- Conditions
- Rhinoconjunctivitis
- Keywords
- HDM Allergy, Rhinoconjunctivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Pharm-Olam International
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis
Detailed description
House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.
The proposed observational study is designed to gather information on subjects with HDM-related rhinoconjunctivitis.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDM-Induced Rhinoconjunctivitis Subjects | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis
Key inclusion criteria (6 listed)
- Male or female, aged 18-65 years
- A history of moderate to severe rhinoconjunctivitis (sneezing, rhinorrhoea, itchy nose, nasal blockage, and/or itchy/watery/red/sore eyes) consistent with allergy to HDM for at least 1 year.
- Non-asthmatic, or asthma controlled by Step 1 or 2 treatment as defined by GINA for at least one month.
- Subjects must have a 7-day reflective TRSS (i.e., reflective over the previous 7 days) of ≥12 and must have a score of ≥2 in at least two of the individual symptom components.
- Subjects must have Der p or Der f specific IgE ≥0.35 kU/L as measured by ImmunoCAP®. A blood draw for HDM-specific IgE must be performed during the Screening period.
Key exclusion criteria (2 listed)
- Clinically significant confounding symptoms of allergy to relevant local seasonal allergens (e.g., ragweed, mugwort, tree, grass, mountain cedar, mould) and cannot complete the Screening and Observation period outside the respective allergy seasons.
- Previous immunotherapy treatment with any HDMA for more than 1 month within 5 years prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To Document the combined Total Rhinocnjunctivitis Systom Scores (TRSS) and Total allergy medication score
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinoconjunctivitis, run by Circassia Limited at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Document the combined Total Rhinocnjunctivitis Systom Scores (TRSS) and Total allergy medication score (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2014.